Table 2.

Summary of rFVIIIFc EDs by treatment regimen in the safety analysis set

Treatment regimen
OD (n = 81)Prophylaxis
(n = 89)
Patients with ED milestones, n (%)*,   
 ≥5 31 (38.3) 84 (94.4) 
 ≥10 8 (9.9) 78 (87.6) 
 ≥20 1 (1.2) 76 (85.4) 
 ≥50 0 (0.0) 64 (71.9) 
 ≥75 0 (0.0) 51 (57.3) 
 ≥100 0 (0.0) 24 (27.0) 
EDs, median (range) 4 (0-27) 91 (1-192) 
Treatment regimen
OD (n = 81)Prophylaxis
(n = 89)
Patients with ED milestones, n (%)*,   
 ≥5 31 (38.3) 84 (94.4) 
 ≥10 8 (9.9) 78 (87.6) 
 ≥20 1 (1.2) 76 (85.4) 
 ≥50 0 (0.0) 64 (71.9) 
 ≥75 0 (0.0) 51 (57.3) 
 ≥100 0 (0.0) 24 (27.0) 
EDs, median (range) 4 (0-27) 91 (1-192) 

Safety analysis set (n = 103). Subjects may appear in >1 treatment regimen.

*

An ED is a 24-h period in which ≥1 rFVIIIFc infusion is given. All infusions across the study are counted.

Refers to EDs within the respective treatment regimen.

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